---

---

---

WARNING LETTER

CMS 617539

December 9, 2021
 

Dear Mr. Martha:

During an inspection of your firm located in Northridge, California, on June 7, 2021 through July 7, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MiniMed 600 series insulin infusion pumps, and software and remote controllers used in conjunction with the Paradigm and MiniMed series insulin infusion pumps.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

This inspection revealed the devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)] in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  You may find the Act and FDA’s regulations through links in the FDA’s home page www.fda.gov.  We received your responses from Sean Salmon, Executive Vice President and President Diabetes Operating Unit, and Chirag Tilara, Vice President, Quality Management Representative, dated July 28, September 3, October 8, November 5, and December 3, 2021, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, that was issued to your firm on July 7, 2021.  We have considered these responses in relation to our observations noted during the inspection, which include, but are not limited to, the following:

1.  You failed to adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a).

a.  Specifically, in June 2016, your firm initiated CAPA (b)(4)#299677 to address anincrease in complaints of damaged retainer rings (clear retainer rings) in the MiniMed 600 Series Insulin Infusion Pumps.  Your investigation determined the device failures were caused by the (b)(4) retainer ring, which in turn caused a (b)(4).  A damaged retainer ring may result in the over or under-delivery of insulin, which may lead to hypoglycemia or hyperglycemia.Beginning August 2019, your firm began releasing the re-designed pumps (which were manufactured with a black retainer ring) for distribution.  You began notifying customers of retainer ring failures in November 2019.  FDA determined that there was a reasonable probability that the use of, or exposure to, the pumps manufactured with the clear retainer ring would cause serious adverse health consequences, including severe hypoglycemia which can result in loss of consciousness, seizure; severe hyperglycemia which can result in diabetic ketoacidosis or hyperosmolar hyperglycemic state, metabolic abnormalities; or death and classified the recall (RES84430) as class 1.  However, your firm failed to adequately implement procedures for corrective and preventive action (CAPA) in that you failed to adequately analyze all sources of quality data, failed to identify actions needed to correct nonconforming product, and you did not appropriately verify or validate the change to your device to ensure corrective and preventive actions taken were effective and did not adversely affect the finished device.  While you implemented your procedure, we disagree with your characterization of the risk threshold which led to a conclusion of a lower risk than was appropriate.  For example:

i.   Your CAPA System procedure (SOP114-01DOC, Effective Date 5/19/2015, Version L) requires your firm to determine whether distributed product is potentially affected by a nonconformance and to conduct additional risk assessment activities per the Product Risk Management Process (SOP104- 08, Version W).  In June 2016, your firm conducted a (b)(4)16-1051, Version A) which, per your Product Risk Management Process, outlines affected product in the field, and is a risk assessment and health hazard evaluation for informing field corrective action (“FCA”) decisions.  Based on FDA’s own evaluation of risk, your outcomes of risk assessment do not appear to be appropriate.  In conducting your (b)(4) you did not accurately calculate the risk associated with the failed retainer rings in the MiniMed 600 Series Insulin Infusion Pumps because your risk calculation formula underestimated the probability of occurrence of harm, resulting in your firm classifying the risk as “(b)(4)” (zone (b)(4)) (b)(4)” (zone (b)(4)).  Consequently, your firm did not initiate a correction or removal to address the defective devices from the field because per your (b)(4), the risk of serious adverse health consequences was “improbable.”

ii.   In March 2021, your firm revised your Product Risk Management Process (SOP104-08, Version AL), which updated the formula for risk calculation; however, this also did not result in accurate risk calculation.  The updated formula uses the “total shipment of affected product” which again underestimates the probability of occurrence because the number of products shipped includes devices not in use by patients (e.g., devices shipped to distributors that have not yet been distributed to customers). Further, the update also changed the parameters on the risk evaluation matrix, increasing the (b)(4) parameters (zones (b)(4)) and (b)(4) parameters (zone (b)(4)), thus requiring a higher occurrence for a harm to be classified as “(b)(4)” (zone (b)(4)).  In June 2021 your firm again repeated the (b)(4), but due to the changes made in your risk evaluation formula and matrix, your firm again classified the risk as “(b)(4)” (zone (b)(4) (zone (b)(4)).

iii.   Your firm did not identify the actions needed to control devices already in distribution. As previously discussed, your firm’s justification in June 2016 for not initiating a recall was based on your firm’s underestimated risk calculation.  Per your Product Review Board Decision Form, dated September 2, 2016 and signed by your VP/President IIM Diabetes on October 3, 2016, while your firm initially planned to develop a customer communication regarding the reservoir retainer ring issue, the decision to not initiate a customer communication was based on “(b)(4).”  Your firm then (b)(4) and (b)(4), each time using the (b)(4) and each time (b)(4); your firm consequently did not initiate a recall until November 20, 2019.  From initiation of CAPA (b)(4)#299677 in June 2016 to November 20, 2019, the date you initiated the recall, you received over 74,000 retainer ring complaints, with over 57,000 of those reported to FDA as MDRs.

iv.   After you initiated the recall of the MiniMed 600 Series Insulin Infusion Pumps on November 20, 2019, your firm further failed to implement changes in your methods and procedures needed to correct and prevent the recurrence of quality problems.  Your recall consisted of a customer notification informing customers with affected insulin pumps to examine their devices for retainer ring damage and to contact Medtronic for a replacement pump if damage was noted; if no damage was noted by the customer, your notification instructed customers to continue using the device and to examine the retainer ring if the device was dropped or bumped.  Thus, after redesigning the retainer ring to prevent further risk, you failed to adequately remove the pumps containing the older, less robust ring from the market.

v.   Your firm failed to verify and/or validate the corrective and preventive actions to ensure the action taken was effective to prevent recurrence of the nonconformance and did not adversely affect the finished device.  Your firm began releasing the re-designed pump with the black retainer ring beginning August 2019 and closed CAPA (b)(4)#299677 as effective on October 2, 2020. Per your CAPA effectiveness plan, your firm compared the complaint rate of the newly released pumps (b)(4) to the complaint rate of the previous pump design with the clear retainer ring (b)(4)…”  You concluded the effectiveness criteria were met because the complaint rate for the re-designed pumps was (b)(4) while the complaint rate for the previous design was (b)(4).  However, you received 322 complaints during the (b)(4) effectiveness check period ((b)(4) to (b)(4)), and as of May 25, 2021, you had received a total of (b)(4) complaints of defective black retainer rings.  You did not re-evaluate the effectiveness of your corrective and preventive actions to determine whether CAPA (b)(4)#299677 should be re-evaluated.

b.  Specifically, your firm initiated CAPA (b)(4)#401464 on June 29, 2018, to address a cybersecurity vulnerability with the remote controllers used with your Medtronic MiniMed 508 Insulin Infusion Pump and your MiniMed Paradigm Insulin Infusion Pumps.  The identified cybersecurity vulnerability revealed unauthorized individuals could (b)(4).”  The root cause investigation in CAPA (b)(4)#401464 indicated the “(b)(4).”  In evaluating the risk of patient harm, your firm determined the lack of (b)(4) that could lead to delivery of (b)(4) could result in catastrophic harm to patients.  Per your CAPA (b)(4)#401464, to address the root cause of the lack of cyber security requirements in the design, all current and future Medtronic Diabetes software products would be evaluated for encryption security requirements.  Your firm also discontinued the manufacture and distribution of the Paradigm Pump products and scrapped remaining inventory of the remote controllers; however, these corrective actions did not address the devices in the field.  While your firm initiated a recall of 15,787 remote controllers shipped to customers in the previous four years, you have distributed over (b)(4) remote controllers since its release in 1999, and you did not notify all customers of this safety issue.

We have reviewed your responses and conclude that they are not adequate because you have not yet provided evidence of implementation for all corrections and corrective actions. We acknowledge your firm has committed to replacing MiniMed 600 Series Insulin Infusion Pumps with the clear retainer ring for all US customers, regardless of warranty status, and will retrieve all Medtronic MiniMed remote controllers from active users, and opened CAPA 539888 in order to track completion of your proposed corrective actions.

You stated you have updated relevant procedures, including but not limited to the risk management procedures, including Product Risk Management Process (SOP104- 08DOC), Risk Management Post Production Procedure (DOP104-068DOC), your recall procedure, Diabetes FCA Program Governance (10578148DOC), to address observation 1 on the FDA 483. You also state you will no longer use a device’s warranty status as a factor in determining the scope of recalls associated with the risk patient harm. Additionally, you state you have updated the Medtronic Internal Message Guide to characterize the field action as a recall to US customers, and opened CAPA 539942 to investigate reports of black retainer ring damage “in light of complaints that have been received.”

We acknowledge that you provided a copy of Engineering Report; NGP 6015265-020 Retainer Ring Damage Investigation, Version B in which you conclude that no manufacturing or design non-conformance was identified. However, you also stated that you have opened CAPA (b)(4)#539942 to further investigate damaged retainer rings and that activity is still ongoing.

You have also provided DOP104-068DOC, Risk Management Post Production Procedure, Revision U. This procedure is not adequate.  You have (b)(4) for the (b)(4) “Medtronic MiniMed believes the (b)(4) is common practice in the industry”, however you have not provided adequate justification to demonstrate that it is appropriate for your risk calculation.  For example, on pg. 200 of “Appendix B_1 of 2” provided in your response dated July 28, 2021 you provided the number of MiniMed 600 Series pumps with clear retainer rings shipped to the field as of February 28, 2021.  There is a large difference between the number of products shipped ((b)(4)) and number of products actually in use in the field ((b)(4)% of product shipped).  It is unclear to us if the difference was due to the number of devices currently with distributors.  If that is not the case, using the number of products shipped (including devices that are not in use by patients) could under- estimate the probability of occurrence of hazardous situations, even after subtracting products currently with distributors.

In addition, you started (b)(4) in (b)(4) but did not (b)(4) (SOP104-08DOC, Revision AP), stating that the one-year delay was “(b)(4)”, however you should not have delayed implementing the (b)(4) method.  You further attempted to justify your interpretation of the (b)(4) in your July 2021 response as follows: “(b)(4), etc.) (b)(4)”.  However, you have not explained how your (b)(4) i.e., that for (b)(4)” as the (b)(4), especially when the (b)(4).

Following change in the (b)(4) situations, you have also re-evaluated your risk zone classification matrix in March 2021 (Change Order QCH00047208, SOP104-08 DOC, Revision AL), stating that “t(b)(4)”, which resulted in changes in classification of risk zones. (b)(4): specifically, “(b)(4) from (b)(4).  In Attachment 1.6 of your response provided on July 28, 2021 you stated that your assessment of suitability of the risk acceptability criteria was conducted based on mortality rates associated with type 1 diabetes, however death is not the only serious consequence for population for which insulin pump therapy is indicated.  Other adverse events such as severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) can also present serious harms to users and should be considered in your hazard analysis.  Similarly, your justification for the reassignment of risk zones for (b)(4) events relies heavily on the above calculation of mortality rates only. Furthermore, you argued that, with the removal of the factor of (b)(4) from your (b)(4) of (b)(4).”  However, the risk calculation for (b)(4) and severity of the risk zones are separate issues and should be assessed separately; addressing the risk calculation does not justify changing the risk zone classification to maintain the overall risk levels.  You have not provided adequate information to support that your revised risk zones are clinically acceptable because they appear to be based only on mortality rates, and not all the adverse events that can occur in the intended use population.

In your response, you should explain how your mortality-based risk calculation is appropriate to address all health risks especially as it led to a down-classification of the risk severity, and update your risk zone classifications if necessary. Finally, in your November 5, 2021 update you stated that you evaluated the Issue Impact Assessments (IIAs) initiated in the last (b)(4) and identified 20 IIAs that require remediation to reflect the (b)(4) per DOP104-068DOC, (b)(4) that is planned to be complete by (b)(4). However, as it is unclear if your revised procedure is adequate and because this corrective action is not yet complete, we cannot evaluate the adequacy at this time.

In summary, your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training  will prevent reoccurrence of the identified deficiencies.  In your November 5, 2021 update you stated that you completed a retrospective review of CAPA effectiveness criteria and of CAPA effectiveness monitoring thresholds but 38 CAPAs were identified as requiring remediation and/or clarification and 14 CAPAs were identified as requiring a new complaint monitoring plan.  You should remediate those CAPAs using an adequate risk analysis and provide a summary of your review and remediation efforts.

2.  You failed to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c).

a.  Your firm failed to investigate over 800 complaints of defective black retainer rings. In June 2016, your firm initiated CAPA (b)(4)#299677 to address an increase in complaints of damaged retainer rings in the MiniMed 600 Series Insulin Infusion Pumps; as part of the CAPA investigation, your firm determined the retainer ring required re-design, and you changed the retainer ring from a clear (b)(4) ring to a black (b)(4) ring.  You began releasing the re-designed pump with black retainer ring in August 2019, and you closed CAPA (b)(4)#299677 as effective October 2020.  From December 2019 to May 2021, you received 887 complaints of defective black retainer rings; in 772 of the 887 complaints your firm referenced CAPA (b)(4)#299677 as the “Formal Investigation

Reference Number” even though this CAPA was an investigation of the previous clear retainer ring design.  For example:

i.  On January 21, 2020, you received a complaint (CASE-2020-00056605) from a customer reporting a crack on their insulin pump reservoir compartment, and damage to the retainer ring.  Your product analysis on the returned device confirmed the device had a “partially broken retainer, cracked reservoir tube lip, missing reservoir tube lip O-ring, and broken reservoir tube lip.”  On April 24, 2020, you determined no formal investigation was necessary due to existing/previous formal investigation and referenced CAPA (b)(4)#299677.  You closed this complaint on April 24, 2020.

ii.  On February 20, 2020, you received a complaint (CASE-2020-00139368) from a customer reporting they experience hyperglycemia, with blood glucose levels of 450 mg/dL.  The customer stated that the lip ring was missing.  Your product analysis on the returned device confirmed the device was missing the reservoir retainer ring and the reservoir tube lip O-ring, and the reservoir would not stay locked in place due to the missing retainer.  On May 8, 2020, you determined no formal investigation was necessary due to existing/previous formal investigation and referenced CAPA (b)(4)#299677. You closed this complaint on May 8, 2020.

iii.  On April 7, 2020, you received a complaint (CASE-2020-00260639) from a customer experiencing a high blood glucose level of 434 mg/dL.  The customer reported that the retainer ring was loose, and the reservoir did not lock into place when inserted into the pump.  Your product analysis on the returned device confirmed a broken retainer and missing reservoir tube O- ring, and the reservoir did not lock into place.  On June 5, 2020, you determined no formal investigation was necessary due to existing/previous formal investigation and referenced CAPA (b)(4)#299677.  You closed this complaint on June 6, 2020.

b.  Your firm failed to adequately investigate a complaint in which the customer reported (b)(4) of insulin that were not programmed by the customer. You received a complaint on December 25, 2019 (CASE-2019-00921665) where the customer alleged that their low blood glucose was the result of over-delivery of insulin by their Paradigm Insulin Infusion Pump (Model MMT-715WWS), which per the (b)(4), reflected (b)(4) that were not programmed by the customer. The device was returned to your firm for analysis and the complaint was escalated to your cybersecurity Incident Response Management Team. Your investigation included a review of the downloaded CareLink data, in which the (b)(4) reported by the customer were not reflected. However, your firm’s investigation did not include reviewing the actual pump history to verify the presence of the additional (b)(4). This complaint was closed June 26, 2021 as “the cause of the event cannot be determined, as product analysis found no failure or anomaly in the device.”

c.   Your firm failed to adequately investigate complaints of Enlite3 MMT-7020A glucose sensor failures.  You received two complaints of sensor failures, both of which were closed as “analysis is not required as this complaint is not reportable, and the sensor lot number is unknown.”  However, there is no evidence in either complaint record that technical support attempted to determine the lot numbers when communicating with the complainants, even though your Guides, Troubleshooting, Glucose Sensor procedure (DOP114-691DOC, Revisions AL and AM) requires all service notifications to include a lot or batch number for the product.  Furthermore, while your Failure Analysis-Glucose Sensor Products procedure (DOP830DOC, Version V) indicates expired sensors are not required to be analyzed, it is not clear how your firm determined the sensors were expired when neither complaint record lists an expiration date, and you failed to determine the lot or batch number of the returned sensors.  Last, your Failure Analysis-Glucose Sensor Products procedure does not include MDR reportability as a requirement for sensor analysis.

d.  Your firm failed to adequately investigate reported issues with your CareLink software that your firm manufactures; this software uses information transmitted from insulin infusion pumps and glucose meters to create reports intended to assist users with diabetes management.  Of the 25 complaints reviewed during our inspection, your firm documented “software error unknown” in 20 of the complaints; however, there is no evidence in your complaint records that technical support attempted to determine the version of software used by the device in order to conduct an investigation.  During the inspection, your VP of Quality Assurance explained to our investigator that all versions of the software are maintained and could be analyzed to investigate the reported software errors.

We have reviewed your responses and acknowledge you have opened CAPA 539889 to track completion of your proposed corrective actions, including updating complaint investigation and post market trending, as well as implementation of an enhanced training program for complaint handling, technical support, and failure analysis personnel.  You have also committed to performing a retrospective review of complaint files for the issues identified on the FDA 483, Inspectional Observations.

In your initial response, you acknowledge CAPA (b)(4)#299677 should not have been used to justify not investigating complaints of the re-designed insulin infusion pumps, and you recognize complaints of damaged black retainer rings should have been escalated to a new formal investigation; you have opened CAPA 539942 to conduct this formal investigation.  However, your response does not address why your firm deemed the original CAPA (b)(4)#299677 as adequate justification for not investigating over 800 complaints in the re-designed pump, nor does it address changes made to prevent recurrence of similar events.

Your response indicates you conducted further analysis of complaint CASE-2019-00921665, in which the customer received (b)(4) not programmed into the device; in your supplementary investigation, your firm reviewed the downloaded pump history file and found (b)(4) of similar size to those recorded in the complaint.  Your supplementary investigation concluded the extra (b)(4) were not received over (b)(4), which “rules out the possibility of a cyber security incident.”  We acknowledge your firm has updated your Failure Analysis, Paradigm (DOP114-858DOC) and Failure Analysis, NGP (DOP114- 888DOC) procedures, and will update failure analyses as warranted; however, your response does not address your firm’s initial limited investigation, nor does it address changes made to prevent recurrence of similar events.

Your response also describes further investigations of the two complaints of Enlite3 MMT- 7020A glucose sensor failures.  Per your response, your firm was able to narrow down and/or determine lot numbers of the sensors via patient history and reassessment of complaint files. In your reassessment you conducted a Lot History Review (LHR) and determined for both complaints “there were no process deviations or out of specification test results observed that would have contributed to a sensor performance issues.”  We acknowledge you opened CAPA 541992 to investigate methods to reliably investigate and analyze sensors; however, as this corrective action is not yet complete, we cannot evaluate the adequacy at this time.

We also acknowledge your firm committed to implementing a new failure analysis process specific to software complaints, and opened CAPA 541994 to investigate and identify actions needed, and complaints with “software error unknown” will be investigated as part of that CAPA.   However, as part of your corrective actions are not yet complete, including your, retrospective complaint review and systemic complaint investigation processes and training, we cannot evaluate the adequacy of your response at this time.

Our inspection also revealed that your insulin infusion pump devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting.  Significant deficiencies include, but are not limited to, the following:

3.  Your firm failed to submit a report to FDA no later than 30 calendar days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

For example, the information included for complaint #CASE-2020-00236012 describes an event in which your firm’s MiniMed Insulin Pump malfunctioned; after using the device the patient exhibited low glucose reading of 36 mg/dL and was treated with food.  We believe that the treatment received by the patient was necessitated to preclude permanent impairment of a body function or permanent damage to a body structure.  There is no information included in the firm’s complaint file that rules out the device may not have caused or contributed to the referenced serious injury.  As such, the referenced complaint meets the definition of a reportable serious injury, as defined in 21 CFR 803.3. The firm became aware of the event on March 27, 2020. However, your firm did not submit an MDR to the FDA.

The adequacy of your firm’s response dated July 28, 2021 cannot be determined at this time.  The response noted that your firm is implementing systemic corrective actions, including updates to its reportability criteria, a retrospective review of the complaints and staff training.  However, your firm did not provide documentation or evidence that all the corrections and corrective actions, including submission of the referenced serious injury MDR, have been implemented and completed as they are still in progress.

The adequacy of your firm’s response dated September 3, 2021 also cannot be determined at this time.  Your response provided an update to its planned or newly added corrective actions, including identification and submission of reportable events associated with retainer ring damage complaints, and implementation of late regulatory review process.  However, your firm did not provide documentation or evidence that all the corrections and corrective actions, including submission of the referenced serious injury MDR and planned re-evaluation of its reportability criteria, have been implemented and completed as they are still in progress.

The adequacy of your firm’s responses dated October 8, November 5, and December 2, 2021 also cannot be determined at this time.  Your responses provided an update to the planned corrective actions.  You provided your new MDR Training Program.  However, you also report that training of personnel will not be completed until (b)(4). You also provided D00603958 MDR Decision Alignment with Risk Management Remediation Plan for Diabetes.  It is unclear if this plan incorporates an adequate risk analysis (see review under item #1) and you state that your planned actions will not be completed until (b)(4). You did not provide documentation or evidence that all the corrections and corrective actions, including submission of the referenced serious injury MDR and planned re-evaluation of its reportability criteria, have been implemented and completed as they are still in progress.

4.  Your firm failed to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

For example, the information included for Complaints #CASE-2018-00270399 and #CASE-2018-00437534 reasonably suggests that your firm’s insulin pump malfunctioned (e.g. broken or missing retainer ring) while in use.  The same malfunction is the subject of the recall Z-0956-2020 for the same device.  Per the 1995 Preamble, a malfunction is reportable if the manufacturer takes, or would be required to take, an action under section 518 or 519(g) of the FD&C as a result of the malfunction of the device or other similar devices {60 FR 63578, 63585 (Dec. 11, 1995)}. Please note that the preamble reference is section 519(f), but the appropriate designation for the section is now section 519(g) due to amendments to the FD&C Act.  There is no information included for the complaint files that justifies that the malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur.  As such, your firm should have submitted within the required timeframes, an MDR for each MDR reportable event subject of the referenced complaints.  The corresponding MDRs 2032227-2021-157630 and 2032227-2021-157620 were received by FDA beyond the required 30 calendar days timeframe.

The adequacy of your firm’s response dated July 28, 2021 cannot be determined at this time.  The response noted that your firm is implementing systemic corrective actions, including updates to its reportability criteria, a retrospective review of the complaints and staff training. However, your firm did not provide documentation or evidence that all the corrections and corrective actions, including the planned assessment of its reportability criteria, have been implemented and completed as they are still in progress.

The adequacy of your firm’s response dated September 3, 2021 also cannot be determined at this time.  Your response provided an update to its planned or newly added corrective actions, including identification and submission of reportable events associated with retainer ring damage complaints, and implementation of late regulatory review process.  However, your firm did not provide documentation or evidence that all the corrections and corrective actions, including the planned re-evaluation of its reportability criteria, have been implemented and completed as they are still in progress.

The adequacy of your firm’s responses dated October 8, November 5, and December 2, 2021 also cannot be determined at this time.  Your response provided an update to the planned corrective actions.  You provided your new MDR Training Program.  However, you also report that training of personnel will not be completed until (b)(4).  You also provided D00603958 MDR Decision Alignment with Risk Management Remediation Plan for Diabetes.  It is unclear if this plan incorporates an adequate risk analysis (see review under item #1) and you state that your planned actions will not be completed until (b)(4).  You did not provide documentation or evidence that all the corrections and corrective actions, including submission of the referenced serious injury MDR and planned re-evaluation of its reportability criteria, have been implemented and completed as they are still in progress.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies.  Your firm should investigate and determine the causes of any deficiencies, and take prompt actions to correct the deficiencies and bring the products into compliance. Failure to promptly correct these deficiencies may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Additionally, premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will not be approved until the deficiencies have been corrected.  Also, should FDA determine that your devices do not meet requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices. If you believe that your products are not in violation of the FD&C Act and FDA regulations, please provide us with your reasoning and any supporting information for our consideration within fifteen business days.

You should schedule a teleconference with FDA to further discuss your response to this Warning Letter, particularly in response to your revised risk assessment (please see item 1 above) in more detail. Please notify FDA in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted Quality System and MDR reporting deficiencies, as well as an explanation of how your firm plans to prevent these deficiencies, or similar deficiencies, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Your firm’s response should be comprehensive and address all deficiencies included in this Warning Letter.

Your response should be sent to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at [email protected]. Please identify your response with CMS Case #617539.  If you have questions about the contents of this letter, please contact Compliance Officer Jamie M. Bumpas at 214-253-5336 or via email at [email protected].

Finally, you should know that this letter is not intended to be an all-inclusive list of the deficiencies at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific deficiencies noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the deficiencies, and take prompt actions to correct the deficiencies and bring the products into compliance.

Sincerely,

/S/
Shari J. Shambaugh
Program Division Director
Office of Medical Device & Radiological Health
West/Division 3

/S/

Timothy T. Stenzel, M.D., Ph.D.
Director
OHT 7: Office of In Vitro Diagnostics and
Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc:
Sean Salmon, Executive Vice President & President
Diabetes Operating Unit
Medtronic, Inc.
[email protected]

Chirag Tilara, Vice President, Quality
Medtronic, Inc.
[email protected]